Is Nomlabofusp legal in the United States?

A replacement for frataxin, the protein people with Friedreich ataxia are missing. It is joined to a short peptide that helps it get into cells, and given as a shot under the skin. In 55 adults across two short safety studies, it raised frataxin in cheek cells, skin and blood platelets. Whether that changes the disease is the question for a 150 person final-stage trial. That trial began in August 2026 and reports in 2029.

Friedreich ataxia is caused by too little frataxin, a protein that works inside the cell's power plants, the mitochondria. Nomlabofusp is an attempt to put the protein back.

How it works: In people, three things are known. A shot under the skin is absorbed fast.

Approval history: Not FDA approved. A mid-stage study, where everyone knows they are getting the drug, is signing people up. A final-stage study (NCT07778836, 150 people) started 5 August 2026, with its main results expected by July 2029.

Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.

The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for Nomlabofusp on the reviewed date. It is not a legal opinion. Rules change. Bringing a compound into the country, prescribing it and owning it can each be treated differently. Check with the agency before you act on anything here.

Check FDA directly

Whether Nomlabofusp is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in the United States. Before you compete or get tested, look up Nomlabofusp by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.

• WADA Prohibited List
• Global DRO (check a named product)
• USADA (US athletes)
• Operation Supplement Safety (US service members)

The rules you compete or serve under decide this, not this page.